AccessGUDID - DEVICE: Cyst Puncture Needle without Stylet (07350025912318)

GUDID

Device Identifier (DI) Information

Brand Name: Cyst Puncture Needle without Stylet
Version or Model: 14804
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vitrolife Sweden AB

Primary DI Number: 07350025912318
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 631805488 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47994	Endoscopic cyst-aspiration set	A collection of sterile devices designed to stabilize and aspirate a cyst or other internal anatomical structure under direct endoscopic vision during a surgical procedure, typically enabling aspiration of fluid without leakage into the surrounding anatomy (e.g., the peritoneal cavity). It typically consists of a long, slender, sharply-pointed, metal needle (e.g., stainless steel) within an aspiration tube [e.g., stainless steel or polycarbonate (PC)] that is applied to the lesion with suction; it may include adaptors and tubing to connect to the source of suction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K862365	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c025f4f0-590e-4d51-a0b7-0ac1aa3e1c2d
Public Version Date: November 28, 2019
Public Version Number: 4
DI Record Publish Date: September 14, 2016